QuidelOrtho Receives Health Canada Approval for Quidel® Triage® PLGF Test for Laboratory Use in Canada

Rhea-AI Summary

QuidelOrtho Corporation (QDEL) receives Health Canada approval for Triage PLGF test, aiding in preterm pre-eclampsia diagnosis and delivery prognosis. The test detects angiogenic imbalance, crucial for maternal and fetal health, with fast results and reduced maternal adverse outcomes.

Insights

Medical Research Analyst

The recent approval of QuidelOrtho's Triage PLGF test by Health Canada represents a significant advancement in the field of maternal-fetal medicine. The ability to quantitatively determine placental growth factor levels provides clinicians with a critical tool for early detection and management of pre-eclampsia, a condition that can have severe consequences for both mother and child. The test's high accuracy and rapid results could lead to a decrease in adverse maternal outcomes by as much as 20%, as indicated by recent studies.

From a medical research perspective, the Triage PLGF test's reliance on a single biomarker simplifies the diagnostic process compared to alternative approaches requiring multiple biomarkers. This simplification is likely to enhance its adoption in various healthcare settings, potentially leading to a standardized approach in the diagnosis of pre-eclampsia across Canada.

Healthcare Economist

The approval of the Triage PLGF test in Canada not only has clinical significance but also economic implications for the healthcare system. Pre-eclampsia is associated with considerable healthcare costs due to increased maternal and neonatal morbidity and mortality. By facilitating early diagnosis and potentially reducing the incidence of adverse outcomes by 20%, the test could lead to significant cost savings for the healthcare system.

Moreover, the test's compatibility with the Triage MeterPro instrument, suitable for both urban and rural settings, may help in alleviating healthcare disparities by enabling access to advanced diagnostic tools in less-resourced areas. This could result in more equitable healthcare delivery and further economic benefits through the prevention of costly complications associated with pre-eclampsia.

Market Research Analyst

The introduction of the Triage PLGF test into the Canadian market may influence the competitive landscape of in vitro diagnostics. QuidelOrtho's test differentiates itself by providing quick and accurate results using a small footprint device, which could disrupt current practices that rely on larger laboratory analyzers. This strategic positioning allows QuidelOrtho to tap into a niche market segment that values rapid and reliable point-of-care testing solutions.

Given the prevalence of pre-eclampsia in up to 5% of pregnancies in Canada, the demand for such diagnostic tests is substantial. The ability of the Triage PLGF test to integrate into existing clinical management guidelines and deliver results within 15 minutes presents a compelling value proposition to healthcare providers, potentially driving market adoption and growth for QuidelOrtho.

Aiding in the diagnosis of preterm pre-eclampsia and prognosis of delivery in symptomatic women

SAN DIEGO--(BUSINESS WIRE)-- QuidelOrtho Corporation (Nasdaq:QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, has received approval from Health Canada for its Triage PLGF test for laboratory use in Canada. The Triage PLGF test is a fluorescence immunoassay to be used with the small footprint Triage MeterPro^® Instrument for the quantitative determination of placental growth factor (“PLGF”) in maternal plasma specimens. The test is intended to detect the presence of angiogenic imbalance, a consequence of abnormal placentation and poor blood flow in the placenta, which can lead to maternal and fetal complications of pregnancy, including pre-eclampsia.¹

Pre-eclampsia is a serious disorder that affects up to 5 percent of pregnancies in Canada.² The Triage PLGF test is used with other clinical information to aid in the diagnosis of preterm pre-eclampsia and in the prognosis of short-term delivery in women presenting with signs and symptoms of pre-eclampsia after 20 weeks and prior to 35 weeks of gestation. Diagnosis of pre-eclampsia indicates delivery within 14 days.³

“When signs or symptoms of pre-eclampsia are present, it is critical to the health and safety of the mother and her unborn baby that clinicians have the information necessary to determine the optimal course of action to achieve the best possible outcome for the pregnancy,” said Bernard Michaud, Country Director, Canada at QuidelOrtho. “The Triage PLGF test is intended to help clinicians diagnose pre-eclampsia sooner and may provide them with information on whether the pregnancy is likely to deteriorate within the next 14 days, allowing for a better patient care management plan.”

Angiogenic imbalance plays a central role in the pathophysiology of preterm pre-eclampsia and places the pregnancy at risk for maternal complications, like HELLP syndrome and eclampsia, and fetal complications, like prematurity and stillbirth. With the Triage PLGF test, clinicians can be positioned to better detect angiogenic imbalance and assess the risk for these complications. The Society of Obstetricians and Gynecologists of Canada (SOGC) guidelines indicate the measurement of angiogenic markers, such as those detected by the Triage PLGF test, because of strong clinical evidence supporting their use to aid in the diagnosis of pre-eclampsia and prognosis for adverse pregnancy outcomes.⁴

The Triage PLGF test delivers results in approximately 15 minutes and provides high accuracy to support the clinical diagnosis of pre-eclampsia needing delivery within 14 days. When integrated into a clinical management guideline, the Triage PLGF test can lead to faster diagnosis and a 20% reduction in maternal adverse outcomes.⁵ The Triage PLGF test is unique because it measures a single biomarker on the Triage MeterPro instrument, unlike other tests which require two biomarkers measured on a larger-footprint laboratory analyzer. The Triage PLGF test is available to customers in Canada for use with the Triage MeterPro instrument. The Triage MeterPro instrument is easy to use with robust quality control and would be suitable for urban and rural laboratory settings, delivering Triage PLGF test results quickly.

Resources:

1.	Redman CWG, Sargent IL. Pre-eclampsia, the placenta and the maternal systemic inflammatory response—a review. Placenta. 2003;24 Suppl A:S21-7. doi:10.1053/plac.2002.0930
2.	Ontario Health (Quality). Placental growth factor (PLGF)-based biomarker testing to help diagnose pre-eclampsia in people with suspected pre-eclampsia: A health technology assessment. Ont Health Technol Assess Ser. 2023;23(3):1-146.
3.	Quidel Triage PLGF Pack Insert
4.	Magee LA, Smith GN, Bloch C, et al. Guideline No. 426: Hypertensive disorders of pregnancy: Diagnosis, prediction, prevention, and management. J Obstet Gynaecol Can. 2022;44(5):547-571.e1. doi:10.1016/j.jogc.2022.03.002. PMID: 35577426
5.	Duhig KE, Myers J, Seed PT, et al. Placental growth factor testing to assess women with suspected pre-eclampsia: a multicentre, pragmatic, stepped-wedge cluster-randomised controlled trial. Lancet. 2019;393(10183):1807-18. doi:10.1016/S0140-6736(18)33212-4

About QuidelOrtho Corporation

QuidelOrtho Corporation (Nasdaq: QDEL) is a world leader in in vitro diagnostics, developing and manufacturing intelligent solutions that transform data into understanding and action for more people in more places every day.

Offering industry-leading expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine, bringing fast, accurate and reliable diagnostics when and where they are needed – from home to hospital, lab to clinic. So that patients, clinicians and health officials can spot trends sooner, respond quicker and chart the course ahead with accuracy and confidence.

Building upon its many years of groundbreaking innovation, QuidelOrtho continues to partner with customers across the healthcare continuum and around the globe to forge a new diagnostic frontier--one where insights and solutions know no bounds, expertise seamlessly connects and a more informed path is illuminated for each of us.

QuidelOrtho is advancing diagnostics to power a healthier future.

For more information, please visit www.quidelortho.com.

Source: QuidelOrtho Corporation

View source version on businesswire.com: https://www.businesswire.com/news/home/20240306724883/en/

Investor Contact:

Juliet Cunningham

Vice President, Investor Relations

IR@QuidelOrtho.com

Media Contact:

Stephanie Kleewein

Communications Manager

media@QuidelOrtho.com

Source: QuidelOrtho Corporation

FAQ

What is the purpose of QuidelOrtho's Triage PLGF test?

The Triage PLGF test aids in diagnosing preterm pre-eclampsia and prognosis of delivery in women with pre-eclampsia symptoms.

How does the Triage PLGF test help clinicians?

The test helps clinicians detect angiogenic imbalance, assess the risk for maternal and fetal complications, and achieve faster diagnosis with reduced maternal adverse outcomes.

What is the significance of the Triage PLGF test's approval by Health Canada?

Health Canada's approval allows QuidelOrtho to offer the Triage PLGF test for laboratory use in Canada, benefiting clinicians and patients in the region.

What are the potential complications associated with preterm pre-eclampsia?

Preterm pre-eclampsia can lead to maternal complications like HELLP syndrome and eclampsia, as well as fetal complications like prematurity and stillbirth.

How quickly can the Triage PLGF test deliver results?

The test provides results in approximately 15 minutes, enabling prompt decision-making for clinicians.